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The MedWatch November 2009 Drug Safety Labeling Changes posting includes 44 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.
The "Summary Page" provides a listing of drug names and safety labeling sections revised: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm191946.htm
Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:
- Actiq (fentanyl citrate)
- Adenocard (adenosine)
- Adenoscan (adenosine)
- Avandaryl (rosiglitazone maleate and glimepiride)
- Byetta (exenatide)
- Cimzia (certolizumab pegol)
- Cleocin HCL (clindamycin hydrochloride)
- Enbrel (etanercept)
- Humira (adalimumab)
- Lotensin (benazepril hydrochloride)
- Lotensin HCT (benazepril/hydrochlorothiazide)
- Lopressor (metoprolol tartrate)
- Norvir (ritonavir) capsule and solution
- Parnate (tranylcypromine sulfate)
- Plavix (clopidogrel bisulfate)
- Qualaquin (quinine sulfate)
- Rebetol (ribavirin), Soma (carisoprodol)
- Remicade (infliximab)
- Simponi (golimumab)
- Soma Compound (carisoprodol 200 mg and aspirin 325 mg)
- Soma Compound with Codeine (carisoprodol 200 mg, aspirin 325 mg and codeine phosphate 16 mg)
- Tekturna (aliskiren)
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